Balloon Expandable vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis

Balloon Expandable vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis - BASELINE Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50789

Enrollment

100

Registered

2021-05-04

Start date

2021-11-22

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

degenerative aortic valve bioprosthesis Worn-out artificial heart valve

Interventions

Following screening and signing the informed consent form, patients will be randomized in the cathlab or hybrid operating room prior to arterial access: • SAPIEN3 Ultra • EVOLUT R/Pro Patients are a

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: o Age >= 65 years o Failing surgical aortic bioprosthesis requiring valve replacement and eligible for transfemoral TAVI per heart team consensus based on multi-modality imaging assessment (including echocardiography and multidetector CT). o Written informed consent

Exclusion criteria

Exclusion criteria: o Not eligible for Transfemoral TAVI with SAPIEN3 and Evolut R/Pro o Multi-valve defects requiring intervention o Clinically unstable and/or inotropic/vasopressor /mechanical support. o Known mural thrombus in the left ventricle o Presence of a mechanical aortic valve o History of recent (within 1 month) stroke or TIA

Design outcomes

Primary

Measure	Time frame
Primary endpoint is device success by VARC-II at 30 days, defined by: - Absence of procedural mortality AND - Correct positioning of a single prosthetic heart valve into the proper anatomical location AND - Intended performance of the prosthetic heart valve (no prosthesis- patient mismatch and mean aortic valve gradient 30kg/m2). Co-primary endpoint is efficacy at 1 year defined by the composite of all-cause death, disabling stroke and rehospitalization for valve related problems.	—

Measure

Time frame

Primary endpoint is device success by VARC-II at 30 days, defined by: - Absence of procedural mortality AND - Correct positioning of a single prosthetic heart valve into the proper anatomical location AND - Intended performance of the prosthetic heart valve (no prosthesis- patient mismatch and mean aortic valve gradient 30kg/m2). Co-primary endpoint is efficacy at 1 year defined by the composite of all-cause death, disabling stroke and rehospitalization for valve related problems.

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Secondary

Measure	Time frame
Clinical endpoints as defined by the most recent VARC document will be collected in an eCRF (including need for permanent pacemaker). Cardiovascular rehospitalisation Coronary obstruction requiring intervention/operation New conduction disorders Prosthetic valve function, as measured by trans thoracic echocardiography: - Left ventricular ejection fraction (%) - Peak velocity (m/s) - Mean gradient (mmHg) - Effective orifice area (cm2) - Indexed effective orifice area (m2/cm2) - Prosthetic aortic valve regurgitation	—

Measure

Time frame

Clinical endpoints as defined by the most recent VARC document will be collected in an eCRF (including need for permanent pacemaker). Cardiovascular rehospitalisation Coronary obstruction requiring intervention/operation New conduction disorders Prosthetic valve function, as measured by trans thoracic echocardiography: - Left ventricular ejection fraction (%) - Peak velocity (m/s) - Mean gradient (mmHg) - Effective orifice area (cm2) - Indexed effective orifice area (m2/cm2) - Prosthetic aortic valve regurgitation

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Countries

Canada, Denmark, France, Germany, Italy, Netherlands, Portugal, Switzerland, United Kingdom, United States

Contacts

Public ContactR.J. Nuis

Erasmus MC, Universitair Medisch Centrum Rotterdam

r.nuis@erasmusmc.nl010-7038786

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 1, 2026